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Leader Calamine Plus zinc oxide lotion 80 mg/mL; 10 mg/mL Lotion, 177 mL

by Cardinal Health, 110 dba Leader · 177 mL in 1 CONTAINER (70000-0400-1)
NDC 70000-0400-01
🏷️ FDA NDC (as labeled) 70000-0400-1 billing pads the package segment with a zero
OTC On market Non-controlled
🗂️ Data synced Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 70000-0400-1
Product NDC 70000-0400
11-digit billing NDC 70000040001
NCPDP billing unit ML — per mL (volume)
RxCUI 1234532
UNII SOI2LOH54Z, 88AYB867L5
UPC 0096295135145
Application # M016
SPL Set ID 81f29789-f794-1e64-e053-2a91aa0ac85e
Established class (EPC) Copper Absorption Inhibitor
Physiologic effect Decreased Copper Ion Absorption
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-02-15
Route TOPICAL
Dosage form LOTION
Substance ZINC OXIDE; PRAMOXINE HYDROCHLORIDE
GPI-14 90859902934120
GPI class Calamine Plus
GCN Seq No 022061
GCN 65328
HICL code 010079
Ingredient (HICL) Pramoxine Hcl/Calamine
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L3
Therapeutic class — intermediate (HIC2) Protectives
HIC3 code L3P
Therapeutic class — specific (HIC3) Antipruritics,Topical
AHFS code 84:08.00.00
AHFS class Antipruritics And Local Anesthetics
FDB label name CALAMINE PLUS 1%-8% LOTION
FDB brand name Calamine Plus
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 70000-0400-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 70000-0400-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerCardinal Health, 110 dba Leader
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code70000
First marketedFeb 2019
Product typeHuman Otc Drug
Portfolio34 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name CALAMINE PLUS 1%-8% LOTION Ingredient Pramoxine Hcl/Calamine
🧪 What is this product?

Leader Calamine Plus is an over-the-counter topical lotion marketed under FDA's OTC monograph rules. It contains pramoxine hydrochloride, a local anesthetic, and zinc oxide, which functions as a skin protectant and drying agent. These ingredients are typically used together in products intended for minor skin irritation, itching, and related topical discomfort.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII 5TJD82A1ET
    A cooling crystalline substance made synthetically that is added to medicines as a fragrance, flavoring agent, and mild local irritant to produce a cooling or warming sensation on the skin or mucous membranes.
  • UNII H5RIZ3MPW4
    A chemical preservative used to prevent bacterial and fungal growth in medicines. It helps extend shelf life and maintain product safety during storage and use.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

10 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesSH Alcohol 38B 2.5% Camphor Diazolidinyl Urea Fragrances Glycerin Hydroxypropyl Methylcellulose Methylparaben Polysorbate 80 Propylene Glycol Propylparabaren Purified water

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly $0.017 $2.96 / 177 ml
Medicaid paysCMS SDUD · 12 mo $0.0201 $3.56 / 177 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Oct 2022 Feb 2026 Sep 2026 $0.017 $0.013
▲ Up 27% over the last 20 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sunmark Caldiphen 80 mg/mL; 10 mg/mL 49348-0337-36 Strategic 177 ml $0.014 — FDA listed save 17%
GNP Caldyphen 80 mg/mL; 10 mg/mL 24385-0072-82 Amerisource 177 ml $0.017 — Availability likely —
Leader Calamine Plus 80 mg/mL; 10 mg/mLthis 70000-0400-01 Cardinal 177 ml $0.017 — Availability likely —
Foster and Thrive Caldyphen 80 mg/mL; 10 mg/mL 70677-1198-01 Strategic 177 ml $0.017 — Availability likely —
Calamine 80 mg/mL; 10 mg/mL 83324-0053-06 Chain 177 ml $0.017 — Availability likely —
Caladryl 1.36 mg/mL; 78.65 mg/mL; 10 mg/mL 00187-5465-06 Bausch 177 ml — — FDA listed —
calahist 10 mg/mL; 80 mg/mL 00363-9411-97 WALGREEN 177 ml — — FDA listed —
Humco Calagesic 80 mg/mL; 10 mg/mL 00395-0420-96 Humco 177 ml — — FDA listed —
Calamine 80 mg/mL; 10 mg/mL 11344-0136-30 Nice-Pak 177 ml — — FDA listed —
TopCare Calagesic 80 mg/mL; 10 mg/mL 36800-0268-96 TOPCO 177 ml — — FDA listed —
Calamine, Pramoxind HCl 80 mg/mL; 10 mg/mL 37808-0616-30 H 177 ml — — FDA listed —
HEB Calagesic 80 mg/mL; 10 mg/mL 37808-0968-96 H 177 ml — — FDA listed —
Calamine 80 mg/mL; 10 mg/mL 41163-0536-30 United 177 ml — — FDA listed —
Publix Calamine Medicated 80 mg/mL; 10 mg/mL 41415-0420-96 Publix 177 ml — — FDA listed —
Best Choice Medicated Calamine 80 mg/mL; 10 mg/mL 63941-0420-96 Valu 177 ml — — FDA listed —
CVS Calamine Plus 80 mg/mL; 10 mg/mL 69842-0420-96 CVS 177 ml — — FDA listed —
Calamine 80 mg/mL; 10 mg/mL 72288-0436-30 Amazon.com 177 ml — — FDA listed —
Calamine 80 mg/mL; 10 mg/mL 75981-0336-30 Perrigo 177 ml — — FDA listed —
Calamine 80 mg/mL; 10 mg/mL 76162-0336-30 Topco 177 ml — — FDA listed —
Calamine 80 mg/mL; 10 mg/mL 79481-0336-01 Meijer, 177 ml — — FDA listed —
Freskaro Calamine Plus 80 mg/mL; 10 mg/mL 82645-0420-96 Pharma 177 ml — — FDA listed —
Humco Calagesic 80 mg/mL; 10 mg/mL 82645-0922-96 Pharma 177 ml — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2019
On the market since
Feb 2019
📍
2026
Currently FDA-listed
7 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 70000-0400-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
157
Units reimbursed last 4 qtrs
28.9K
Gross reimbursed last 4 qtrs
$579.75
Avg / prescription
$3.69
Avg / unit
$0.0201
Latest quarter Q1 2026
24Rx
Medicaid pays / mL
$0.0201
gross reimbursed
vs
NADAC / mL
$0.0167
acquisition cost
=
Spread
+$0.0034
+20% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
100% MCO
Fee-for-service · 0 Rx Managed care · 157 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: 11,448 units · 123 per 100k residents NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 17,436 units · 57.2 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
57.2123
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New Jersey 123 /100k
2 Texas 57.2 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
70000-0400-01 You're viewing this 177 mL in 1 CONTAINER (70000-0400-1) 2019-02-15 Active

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 38 words ▾

Uses: temporarily relieves pain and itching associated with: rashes due to poison ivy, poison oak, or poison sumac insect bites minor skin irritation minor cuts ​dries the oozing and weeping of poison ivy, poison oak and poison sumac

⏱️ Dosage and Administration 60 words ▾

Adults and children 2 years of age and older: Shake well before using. CLeanse the skin with soap and water and let dry before each use. Apply lotion to the affected area using cotton of soft cloth, not more than 3 to 4 times daily as needed for comfort. Children under 2 years of age: Consult a doctor before use.

⚠️ Warnings 23 words ▾

For external use only Avoid contact with eyes and mucous membranes Ask a doctor before using on children under 2 years of age

🧪 Active Ingredient 5 words ▾

Calamine 8% Pramoxine HCl 1%

🧪 Inactive Ingredients 19 words ▾

SH Alcohol 38B 2.5% Camphor Diazolidinyl Urea Fragrances Glycerin Hydroxypropyl Methylcellulose Methylparaben Polysorbate 80 Propylene Glycol Propylparabaren Purified water

🎯 Purpose 4 words ▾

Skin Protectant External Analgesic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70000-0399-01 · Cardinal 70000-0401-01 · Cardinal →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.